Dernière mise à jour : 23 février 2015
Détails
FichiersGeneric Name:
Ofatumumab
État du projet:
Terminé
Domaine thérapeutique:
Chronic Lymphocytic Leukemia
Fabricant:
GlaxoSmithKline Inc.
Brand Name:
Arzerra
Gamme de produits:
Examen en vue du remboursement
Numéro de projet :
PC0038-000
Indicateur de rendement:
S. O. – Mesures de rendement prédictives
Strength:
20mg /vial
Tumour Type:
Leukemia
Indications:
Chronic Lymphocytic Leukemia
Funding Request:
In combination with chlorambucil, for the treatment of patients with chronic lymphocytic leukemia (CLL) who have not received prior therapy and are inappropriate for fludarabine-based therapy.
Review Status:
Complete
Pre Noc Submission:
Yes
Sponsor:
GlaxoSmithKline Inc.
Submission Date:
Submission Deemed Complete:
Priorisation demandée:
Non demandée
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Clarification:
A delay in the receipt of marketing authorization (NOC) from Health Canada has impacted the review timeline. The submitter provided additional economic information, which further impacted the review timeline.
Recommandation:
Ne pas rembourser
Clarification:
A procedural review request was received from GlaxoSmithKline Inc. on February 6, 2015. As per Section 3 of the pCODR Procedural Review Guidelines, this procedural review request was submitted on the basis that pCODR failed to act in accordance with its procedures in conducting the review, as described in the pCODR Procedures, and that pERC failed to apply its deliberative framework in formulating its recommendation, as outlined in the pERC Deliberative Framework. As per Section 6 of the pCODR Procedural Review Guidelines, the procedural review request was reviewed by the President and CEO of CADTH, with advice from the pCODR Advisory Committee (PAC) Chair and Vice-Chair. It was determined on February 20, 2015, that the grounds for a procedural review request did not exist. As such, a Notification to Implement has been issued for February 23, 2015.
Clarification:
A delay in the receipt of marketing authorization (NOC) from Health Canada has impacted the review timeline. The submitter provided additional economic information, which further impacted the review timeline.
pERC Meeting:
Final Recommendation Issued:
Fichiers
‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.
Dernière mise à jour : 23 février 2015